Characteristics of participants
| N=988 | |
| Gender (M/F) | 366/622 |
| Age (mean±SD) | 46.71±7.70 |
| Trial arm (DMT/placebo) | 420/422 |
| EDSS (median, range) | 6 (3–7.5) |
| SDMT (mean±SD) | 39.86±14.20 |
| 9HPT (mean±SD) | 35.81±19.62 |
| EDSS progression confirmed at 3 months (no. progressed/not progressed) | 197/643 |
| 9HPT worsening (no. worsened/not worsened) | 177/244 |
| SDMT worsening (no. worsened/not worsened) | 173/187 |
EDSS progression was defined as 1 point increase from a baseline EDSS score ≤5.5, or as 0.5 points from a baseline EDSS score >5.5, excluding all clinical visits within 30 days from an attack, and these scores were confirmed at 3 months.36 We estimated the 9HPT worsening as a 20% increase with respect to the baseline score (Lublin et al37; Tur et al36). We calculated the SDMT worsening as a 10% decrease with respect to the baseline score.38 39
DMT, disease-modifying treatment; EDSS, Expanded Disability Status Scale; F, females; 9HPT, Nine-Hole Peg Test; M, males; SDMT, Symbol Digit Modalities Test.